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SOURCES SOUGHT NOTICE

This is a Sources Sought Notice (SSN) ONLY. The U.S. Government is conducting market research only to determine the availability of qualified sources capable of providing Molecular Diagnostic Laboratory Reagents, for Syndromic Testing for Respiratory (including SARS-CoV2), Gastrointestinal (GI) panel, blood culture ID panel, and meningitis testing.
. Potential Contractors are invited to provide a response via e-mail to Contract Specialist Alex Beck at alex.beck1@va.gov by Nov 3, 2023 3:00 pm (PT). Responses will be used to determine the appropriate strategy for a potential acquisition. Please clearly identify any information your company considers sensitive or proprietary. This notice is issued solely for information and planning purposes - it does not constitute a Request for Quotation (RFQ), or a promise to issue an RFQ in the future. This notice does not commit the U.S. Government to contract for any supply or service. Further, the U.S. Government is not seeking quotes, or proposals at this time and will not accept unsolicited quotes in response to this sources sought synopsis. The U.S. Government will not pay for any information or administrative costs incurred in response to this notice. Submittals will not be returned to the responder. Not responding to this notice does not preclude participation in any future RFQ, if any is issued.

BACKGROUND: The Portland VA Health Care System, Portland VA Medical Center, Portland Oregon, has a requirement for a Contractor to provide Molecular Diagnostic Laboratory Reagents, for Syndromic Testing for Respiratory (including SARS-CoV2), Gastrointestinal (GI) panel, blood culture ID panel, and meningitis testing.
Please draft Statement of Work below for requirements.

NAICS: 325413

Interested potential Contractors please provide the following.

1) Company Name, address, point of contact, phone number, email address, and DUNS

Please indicate business size:
Small Disadvantage Business (SDB)____
8(a)____
Historically Underutilized Business Zone (HUBZone)____
Service-Disabled Veteran-Owned Small Business (SDVOSB)____
Veteran-Owned Small Business (VOSB)_____
Economically Disadvantaged Women-Owned Small Business (EDWOSB)_____
Women-Owned Small Business concerns (WOSB)_____
Small Business_____
Large Business_____

Please state if you possess a Federal Supply Schedule (FSS)______. Please state if your FSS Schedule is under Group 66 III Cat 605-2A________

2) Please submit a brief capability statement (maximum two pages) with enough information to demonstrate to the Veterans Affairs that you can provide the required Molecular Diagnostic Laboratory Reagents stated in the Draft Statement of Work below.
**DRAFT STATEMENT OF WORK**
Molecular Diagnostic Laboratory Reagents, for Syndromic Testing for Respiratory (including SARS-CoV2), Gastrointestinal (GI) panel, blood culture ID panel, and meningitis testing.
Purpose
Establish a Base Year plus Four (4) Option Year contract for reagents (kits) to be used on current in-use Molecular Diagnostic instrumentation. VA owns instrumentation for testing. Supporting reagents are used for detection of needed pathogens found in Respiratory specimens, GI specimens, Blood culture ID, and CSF (meningitis).
Scope
Vendor will provide Test Kits and supplies as needed to perform testing on VA owned molecular analyzer, located in the VA Portland Medical Center Microbiology Department.
The instrument must utilize a multiplex PCR (polymerase chain reaction) method, have FDA-cleared assays that test for primarily (a) up to 20 respiratory pathogen targets. Secondary testing capabilities (b) common GI pathogens including viruses, bacteria, and parasites, (c) up to 27 blood culture identification targets, and (d) up to 14 meningitis/encephalitis targets inclusive of bacteria, viruses and fungi.
The instrumentation should have very little hands-on time (5 minutes or less) to set up and have results for respiratory pathogen targets, blood culture, GI pathogens and meningitis/encephalitis targets in one hour. The instrument must perform amplification, detection and analysis in one self-contained system. The instrument includes software that automatically generates a result for each target in a single report.
Requirement
Test kits must be able to be used with current in-use VA owned Biofire equipment
Can perform DNA/RNA extraction, purification and highly multiplexed PCR.
Can generate, detect and analyze PCR melting curves. The analysis includes a meta-analysis of all applicable controls and gene targets required for determination of a single result for each organism included in the multiplex reaction.
Processes reagent pouches to detect multiple nucleic acid targets contained in clinical specimens.
Sensitivity and specificity of the System is comparable to that of common commercially available real-time PCR instruments.
Requires approximately two minutes for set up and completes a run in one hour or less.
Is capable of simultaneous analysis of up to 20 respiratory targets, 27 blood culture targets, 22 gastrointestinal targets and 14 meningitis/encephalitis targets.
Blood culture panel does not rely on gram stain, pouch includes gram negative and gram positive bacteria and yeast.
Ships with a Microsoft Windows®-based computer and analysis software or equivalent.
Has bar code reading capability.
Is fully automated following initial run set-up.
Contains all necessary reagents for sample prep, PCR, and detection and reagents can be stored at room temperature.
Capable of processing up to 88 patient samples per day (if run 24/7)
Location
VA Portland Health Care System, 3710 SW US Veterans Hospital Rd, Portland, OR 97239
Records Management
All records (administrative and program specific) created during the period of the contract belong to VA Portland (VPORHCS) and must be returned to VAPORHCS at the end of the contract.
Panel requirements:
Respiratory:
Viruses
Adenovirus
Coronavirus 229E
Coronavirus HKU1
Coronavirus NL63
Coronavirus OC43
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Human Metapneumovirus
Human Rhinovirus/Enterovirus
Influenza A, including subtypes
H1, H3 and H1-2009
Influenza B
Parainfluenza Virus 1
Parainfluenza Virus 2
Parainfluenza Virus 3
Parainfluenza Virus 4
Respiratory Syncytial Virus
Bacteria
Bordetella parapertussis
Bordetella pertussis
Chlamydia pneumoniae
Mycoplasma pneumoniae
GI:
Campylobacter (C. jejuni/C. coli/C. upsaliensis)
Clostridium difficile (C. difficile) toxin A/B
Plesiomonas shigelloides
Salmonella
Vibrio (V. parahaemolyticus/V. vulnificus/ V. cholerae), including specific identification of Vibrio cholerae
Yersinia enterocolitica
Enteroaggregative Escherichia coli (EAEC)
Enteropathogenic Escherichia coli (EPEC)
Enterotoxigenic Escherichia coli (ETEC) lt/st
Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 (including specific identification of the E. coli O157 serogroup within STEC)
Shigella/ Enteroinvasive Escherichia coli (EIEC)
Cryptosporidium
Cyclospora cayetanensis
Entamoeba histolytica
Giardia lamblia (also known as G. intestinalis and G. duodenalis)
Adenovirus F 40/41
Astrovirus
Norovirus GI/GII
Rotavirus A
Sapovirus (Genogroups I, II, IV, and V)

Meningitis (CSF) panel
Bacteria:
Escherichia coli K1
Haemophilus influenzae
Listeria monocytogenes
Neisseria meningitidis
Streptococcus agalactiae
Streptococcus pneumoniae
Viruses:
Cytomegalovirus (CMV)
Enterovirus (EV)
Herpes simplex virus 1 (HSV-1)
Herpes simplex virus 2 (HSV-2)
Human herpesvirus 6 (HHV-6)
Human parechovirus (HPeV)
Varicella zoster virus (VZV)
YEAST:
Cryptococcus neoformans/gattii
Blood culture ID panel
GRAM-NEGATIVE BACTERIA:
Acinetobacter calcoaceticus-baumannii complex
Bacteroides fragilis*
Enterobacterales
Enterobacter cloacae complex
Escherichia coli
Klebsiella aerogenes*
Klebsiella oxytoca
Klebsiella pneumoniae group
Proteus
Salmonella*
Serratia marcescens
Haemophilus influenzae
Neisseria meningitidis
Pseudomonas aeruginosa
Stenotrophomonas maltophilia*

GRAM-POSITIVE BACTERIA:
Enterococcus faecalis*
Enterococcus faecium*
Listeria monocytogenes
Staphylococcus
Staphylococcus aureus
Staphylococcus epidermidis*
Staphylococcus lugdunensis*
Streptococcus
Streptococcus agalactiae
Streptococcus pneumoniae
Streptococcus pyogenes

YEAST:
Candida albicans
Candida auris*
Candida glabrata
Candida krusei
Candida parapsilosis
Candida tropicalis
Cryptococcus neoformans/gattii*

ANTIMICROBIAL RESISTANCE GENES:
Carbapenemases
IMP*
KPC
OXA-48-like*
NDM*
VIM*
Colistin Resistance
mcr-1*
ESBL
CTX-M*
Methicillin Resistance
mecA/C
mecA/C and MREJ (MRSA)*
Vancomycin Resistance
vanA/B

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